# K972919: Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Inc.
- Decided: Mar 27, 1998 after 232 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921458 (1992). 4 ancestors in all.
87 later devices descend from it; 1 cites it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921458: TMP Microplating System, Techmedica, Inc. (1992) Summary page 1.
- K955729: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K952471: Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod, Bioscience, Inc. (1995). Our OCR of the scanned summary read K952871, FDA’s number for Ridges Plus (Octostop, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bionx Implants, Inc. BIOFIX® SR-PLLA Threaded Rod”.
- K961608: Synthes (U.S.a.) Polypin, Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), 86 descendants of its own
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own
- K060177: KLS Martin Rigid Fixation  - Sterile (2006), 65 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own

## Indications for use
The BioSorb® SR-PDLA Endobrow Screw is intended for use in Endoscopic Browplasty surgery. The Endobrow Screw will be specifically indicated for use to reattach the subdermis to the cranial bone in endoscopic browplasty procedures. The Endobrow Screw is used as a post to tie an absorbable suture to the subdermis. In conjunction with adequate surgical technique, the Endobrow Screw holds the subdermis securely in place to allow for reattachment to the cranial bone. Use absorbable sutures that provide wound support for at least thirty (30) days.

Source page: https://510kreport.com/device/K972919
Methodology: https://510kreport.com/methodology